BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30° MULTI-UNIT ABUTMENT, 3 MMH FOR CAMLOG SCREW-LINE 3.8 MM

    MDR report key: 20632561 · Received November 7, 2024

    Report

    Report Number
    3011649314-2024-00176
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    April 12, 2022
    Report Date
    April 15, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    NHA
    PMA / PMN Number
    K121391
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: G3 (THE G3 IN THE PREVIOUS SUBMISSION WAS INADVERTENTLY LEFT BLANK; IT SHOULD BE (B)(6) 2025), H6 (INVESTIGATION FINDING AND INVESTIGATION CONCLUSION). ADDITIONAL INFORMATION: G1, H6 (TYPE OF INVESTIGATION). CAPA CA-00016. THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS (B)(4). THIS SUBMISSION IS LINKED TO (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED: ,H1,B1, AND B2. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION HAS BEEN COMPLETED; FOLLOWING IS THE DEVICE ANALYSIS CONCLUSION: DHR RESULTS THE DHR WAS REVIEWED FOR INCLUSIVE MULTI-UNIT ABUTMENT LOT# 6005175 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. STOCK PRODUCT REVIEWED RESULTS A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR INCLUSIVE MULTI-UNIT ABUTMENT LOT# 6005175 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS BASED ON THE TRACKING LABEL THE PRODUCT WAS NOTED TO HAVE BEEN RECEIVED AND IN GLIDEWELL'S POSSESSION; HOWEVER, TO DATE THE DEVICE HAS NOT BEEN PHYSICALLY ACCOUNTED FOR AND SENT TO THE COMPLAINT'S TEAM FOR ANALYSIS. THEREFORE, IT IS PRESUMED LOST AT THIS TIME, CAPA 2024-005 WAS OPENED FOR RMA LOST PRODUCT. ROOT CAUSE A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS THE OVER-TORQUING OF THE ABUTMENT AND SCREW DURING THE INITIAL PLACEMENT WHICH MAY HAVE CAUSED A FRACTURE. ADDITIONALLY, IT IS UNCLEAR THE METHODS OF ABUTMENT AND SCREW PLACEMENT USED DURING THE INSTALLATION AND THE INSERTION TORQUE VALUE. ANOTHER PROBABLE ROOT CAUSE IS THAT NOT ENOUGH TORQUE WAS APPLIED TO THE ABUTMENT AND SCREW WHICH MAY HAVE CAUSED THE FRACTURE TO OCCUR OVER TIME. PER THE REPORTED INFORMATION, THE PATIENT HAS A HISTORY OF BRUXISM WHICH MAY HAVE CONTRIBUTED TO THE FRACTURE AS WELL. IFU 012640 REV 2 (INCLUSIVE PROSTHETIC COMPONENTS FOR OEM IMPLANT SYSTEMS) CONTAINS THE FOLLOWING STATEMENT IN THE DELIVER OF FINAL RESTORATION SECTION: "USING THE APPROPRIATE DRIVER IN CONJUNCTION WITH A PROPERLY METERED TORQUE WRENCH, TIGHTEN THE ABUTMENT OR HYBRID RESTORATION TO THE IMPLANT MANUFACTURER'S RECOMMENDED TORQUE VALUE." IFU 012640 REV 2 (INCLUSIVE PROSTHETIC COMPONENTS FOR OEM IMPLANT SYSTEMS) CONTAINS THE FOLLOWING STATEMENT IN THE ADVERSE EFFECTS SECTION: "THE FOLLOWING ADVERSE EFFECTS HAVE BEEN OBSERVED WHEN USING PROSTHETIC COMPONENTS AND ACCESSORIES: COMPONENTS USED IN THE PATIENT'S MOUTH HAVE BEEN ASPIRATED OR SWALLOWED. THE ABUTMENT SCREW HAS FRACTURED DUE TO APPLICATION OF EXCESSIVE TORQUE. THE ABUTMENT IS NOT ADEQUATELY SECURED DUE TO INADEQUATE APPLICATION OF TORQUE." CAPA 2024-005 MANUFACTURER INTERNAL REFERENCE NUMBER: COMP (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED AN INCLUSIVE MULTI-UNIT ABUTMENT WITH ITS SCREW FRACTURED BUT THE IMPLANT REMAINED IN PLACE AFTER THE FINAL PROSTHESIS DELIVERY ON TOOTH 20. THE PROSTHESIS WAS REMOVED WITH NO OBSERVABLE CLINICAL SYMPTOMS OR PERMANENT INJURY REPORTED, THE PATIENT IS DOING WELL. AT THE TIME OF THE SURGICAL PROCEDURE THE PATIENT'S BONE QUALITY WAS TYPE I WITH GOOD ORAL HYGIENE STATUS. IT WAS REPORTED THAT THE PATIENT HAS DIABETES, BRUXISM, AND DRY MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796818 30° MULTI-UNIT ABUTMENT, 3 MMH FOR CAMLOG SCREW-LINE 3.8 MM INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS NHA PRISMATIK DENTALCRAFT, INC. 70-1135-CAM0143 6005175

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention